EUCTR2012-004082-41-DE进行中（未招募）1 期
Monocenter, double blind, randomised, placebo controlled study t evaluate Physostigmin for the Treatment of delirium in perioperative intensive care medicine
Dekan of Faculty of Medicine of Goethe-University Frankfurt0 个研究点目标入组 120 人开始时间: 2013年1月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients of both genders aged > 18 years, < 85 years of ICU C1 after elective or emergency cardio surgery with or without extracorporeal circulation (heart–lung machine and/or extracorporeal membrane oxygenation), with suspected delirium. (May be suspected if a patient does not show adequate improvement of vigilance 24 h after adequate reduction or stop of sedative medicine)
- •- Patients (>18a, <85a) with CAM-ICU diagnosed delirium
- •- Patients of legal capacity and patients with appointed representative or informed consent of an independet consultant
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- hypersensitivity against Physostigminsalicylat, Sodium metabisulfit, Nitrogen
- •- gangrene
- •- mechanical obstipation
- •- mechanical urinary retention
- •- Dystrophia myotonica
- •- Depolarization block after depolarising muscle relaxants
- •- Intoxications with „irreversibly acting cholinesterase inhibitors
- •- closed head trauma
- •- obstructions at gastro-intestinal tract and at urinary tract
- •- neurological diseases
- •- left ventricular ejection fraction < 40%
- •- Simultaneous Participation in other clinical trials or participation ind other clinical trials in the last 30 days
- •- untreated coronary heart disease
- •- wish to have chirldren, pregnancy or nursing
- •- patients with addicitve disorder in medical history
研究者
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